1. Field of the Invention
The present invention relates to bio-analysis system and method, and particularly an improved system and method for genotyping.
2. Description of Related Art
The achievement of the Human Genome Project (HGP) was entirely performed by fluorescence Sanger dideoxyribonucleotide sequencing. Since the completion of the Human Genome Project, more than 30,000 genes that are involved in the function of the body have been found in a single human cell. The information from genetic (DNA) analysis has the potential to revolutionize the diagnosis, prevention and treatment of human diseases. Genetic analysis currently is used for identifying drug resistant strains, infectious disease testing applications in bioterrorism, disease diagnostics and prognostics (cancer, cardiovascular disease, Alzheimer's disease), diagnosis of inherited disorders, molecular tissue pathology, forensic identity/testing and pharmacogenetics (therapy selection, monitoring, adverse). Molecular diagnostics (MDx) is the fastest growing segment in the in vitro diagnostics (IVD) market with global market of approximately $2.5 billion, increasing at 15% CAGR in 2005, up from essentially nothing five years ago. Molecular diagnostics is the detection of DNA variation or RNA expression with the intent to diagnose disease, or to determine the prognosis of the condition. Genetic testing (including cancer screening) is a small but extremely fast-growing component of the market, particularly in the services sector. Nearly all the MDx tests today are based on PCR (polymerase chain reaction) process, which is an enabling technology, generating faster, more specific and more sensitive detection of viral and bacterial infectious disease agents than culture and immunoassay type methods.
Currently, most of the DNA fragment analysis tools (genotyping) applied in laboratories utilize slab gel-based electrophoresis technologies, which have routinely been used for checking DNA properties since their inception more than 20 years ago. However, slab gel electrophoresis for DNA analysis (e.g., HLA SSP typing) is labor-intensive, low throughput and low resolution. Traditional gel-based electrophoresis methods currently used for DNA/RNA analysis take hours, if not days, to produce results with many cumbersome manual procedures, which are subject to human errors.
It is therefore desirable to develop a new system and method to improve resolving power, cost and throughput for genotyping.